MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: canaz, h., karalok, i., topcular, b., agaoglu, m., yapici, z., aydin, s.Dbs in pediatric patients: institutional experience.Childs nerv syst.2018.Doi: 10.1007/s00381-018-3839-1.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Summary: introduction dbs is initially used for treatment of essential tremor and parkinson¿s disease in adults.In 1996, a child with severe life-threatening dystonia was offered dbs to the internal globus pallidus (gpi) with lasting efficacy at 20 years.Since that time, increasing number of children benefited from dbs.Patients and methods we retrospectively evaluated our database of patients who underwent dbs from 2011 to 2017.All patients = 17 years of age at the time of implantation of dbs were included in this series.Subjective benefit rating scale (sbrs), hoehn yahr scale (hys), fahn marsden rating scale (fmrs), clinical global impressions scales (cgi), and yale global tic severity scale (ygt) were used to evaluate clinical outcome.Results between may 2014 and october 2017, 11 children underwent dbs procedure in our institution.Six of them were female and five of them were male.Mean age at surgery was 11.8 ± 4.06 years (range 5¿17 years).In our series, four patients had primary dystonia (pdy) (36.3%), three patients had secondary dystonia (sdy) (27.2%), two patients had jp (18.1%), and two patients had tourette syndrome (ts) (18.1%).Two jp patients under went bilateral stn dbs while the other nine patients underwent bilateral gpi dbs.Sbrs scores were 1.75 ± 0.5 for patients with pdy, 3 ± 0 for patients with jp, 2.5 ± 0.7 for patients with ts, and 2 ± 1 for patients with sdy.Mean fmrs reduction rate was 40.5 for patients with dystonia.Significant improvement was also defined in patients with ts and jp after dbs.None of the patients experienced any intracerebral hemorrhage or other serious adverse neurological effect related to the dbs.Wound complications occurred in two patients.Conclusion there are many literatures that support dbs as a treatment option for pediatric patients with medically refractory neurological disorders.Dbs has replaced ablative procedures as a treatment of choice not only for adult patients, but also for pediatric patients.Wound-related complications still remain the most common problem in pediatric patients.Development of smaller and more flexible hardware will improve quality of children¿s life and minimize wound-related complications in the future.Reported events: patient 8: a (b)(6)-year-old male patient with bilateral globus pallidusinternus (gpi) deep brain stimulation (dbs) for tourette syndrome experienced ¿head skin¿ erosion over the connection point of the leads.Related to this it was noted that the patient experienced t witching due to their ts.Infection was diagnosed so the system was totally removed.Escherichia coli was cultured.The dbs system was ultimately reinserted after antibiotic therapy was completed.

• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7657453
• MDR Text Key: 112992422
• Report Number: 3007566237-2018-01956
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR